IRRAflow continuous irrigation to clear blood and infection inside the head
Official title: Clearance of Intracranial Blood Products by Continuous Irrigation With the IRRAflow System
Run by Icahn School of Medicine at Mount Sinai · NCT06649097 · Data updated 2026-11-12
This trial tests whether the IRRAflow system, which continuously irrigates and drains the brain, clears intracranial blood and treats ventriculitis or abscess better than standard external ventricular drains in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | January 2031 |
| Study ends | July 2031 |
| Registry record updated | October 28, 2025 |
| Trial ID | NCT06649097 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with CT/MRI‑documented intracranial hemorrhage, ventriculitis, or intracranial abscess who are judged by their treating physician to need active fluid exchange and can be enrolled within 72 hours of last known well are appropriate candidates.
✕Probably not a fit
Patients with very low neurologic status (GCS ≤5), fixed and dilated pupils, life‑threatening medical conditions, pregnancy, or who are not candidates for active fluid exchange are unlikely to benefit from this device approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, controlled, post‑market cohort registry comparing the IRRAflow Active Fluid Exchange System to standard external ventricular drains in adults with intracranial hemorrhage, ventriculitis, or intracranial abscess. Eligible patients (age ≥18, radiographic intracranial hemorrhage, indication for active fluid exchange, enrollment within 72 hours of last known well) are enrolled and treated per physician choice with either IRRAflow or standard of care. Radiographic clearance of blood products, device performance, and safety outcomes are collected prospectively and the IRRAS catheter is analyzed when enrollment criteria are met. Additional supportive, medical, or surgical care is provided according to standard practice at the treating center.
Why it matters
Potential benefit: If successful, the IRRAflow system could clear blood and infected fluid faster, potentially reducing infections, repeat procedures, and ICU length of stay.
How similar studies have gone: Small case series and single‑center observational reports of automated irrigation/drainage systems like IRRAflow have shown promising radiographic clearance and safety signals, but large randomized trials are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age \>=18 years of age * Intracranial hemorrhage documented on head CT or MRI scan. * Indication for active fluid exchange evaluated by treating physician. * Signed informed consent obtained by patient or Legal Authorized Representative * Scheduled enrollment and treatment within 72 hours of last known well (LKW) Exclusion criteria: * GCS ≤ 5 * Pregnancy * Fixed and dilated pupil * Life-threatening medical condition
Where it's running
-
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Christopher Kellner — Icahn School of Medicine at Mount Sinai
- Study coordinator: Sukaina Davdani
- Email: Sukaina.Davdani@mountsinai.org
- Phone: (212) 241-2524
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Febuxostat for conservatively managed intracranial hemorrhage
This study tests whether febuxostat can improve outcomes for adults with intracranial hemorrhage who are managed without surgery.
-
Atorvastatin for primary intracerebral hemorrhage
This trial will see if adding atorvastatin to usual care helps adults (18–80) who have a spontaneous intracerebral hemorrhage and are treated within 3–24 hours of symptom onset.
-
Evaluating a new method for draining fluid and blood in brain hemorrhages
This study is testing a new device for draining fluid and blood from the brain to see if it works better than the standard method for patients with brain hemorrhages.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.